EFSA gives green light to six flavouring agents
Europe's risk assessor but industry is still awaiting the outcome
for seven other agents evaluated at the same time.
Following evaluations of 13 aliphatic secondary alcohols, ketones and related esters, a scientific panel at the European Food Safety Authority (EFSA) concluded that there was no safety concern at estimated levels of intake for six of the 13 substances. But there was insufficient data to complete the evaluation of the other substances. EFSA cited the need for EU production figures as well as information on the isomeric composition in order to complete their evaluation. "For seven substances [FL-no: 07.069, 07.100, 07.114, 09.657, 09.658, 09.923 and 09.925] the panel has reservations," reports EFSA on the Flavouring Group Evaluation 63 (FGE.63). European Parliament and Council Regulation (EC) No 2232/96 sets out the basic rules or the use of flavouring substances in or on foodstuffs in the EU. It also lays down a procedure for the establishment of an EU-wide positive list of flavouring substances, that kicked off in July 2000, but nearly eight years on is still incomplete. Participants are hoping that the end of the year could see the positive list finalised. Only those flavouring substances listed may be added to foods. For this latest evaluation, the EFSA panel on additives and flavourings were requested by the European Commission to look into the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the European bloc. In particular, the panel was asked to consider the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No1565/2000. Each flavouring substance is attributed a FLAVIS-number (FL-number) and all substances are divided into 34 chemical groups. The FGE.63 evaluation concerned 13 aliphatic secondary alcohols, ketones and related esters evaluated by the JECFA (59th meeting), and considered in relation to the EFSA evaluation of 35 saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated in the Flavouring Group Evaluation 07 (FGE.07). But for the remaining six of the 13 Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated aliphatic secondary alcohols, ketones and related esters [FL-no: 07.015, 07.123, 07.151, 07.240, 07.249 and 09.924] the panel found "no safety concern at estimated levels of intake as flavouring substances" based on the MSDI (Maximised Survey-derived Daily Intake) approach. A spokesperson at the European Flavour and Fragrance Association informed FoodNavigator.com that the flavour industry is "currently compiling the additional information" required by EFSA's scientific panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food. In its evaluation, as a default the panel uses the Maximised Survey-derived Daily Intake (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. The JECFA includes intake estimates based on the MSDI approach derived from both European and USA production figures. The highest of the two MSDI figures is used in the evaluation by the JECFA. But "in several cases, only the MSDI figures from the USA were available, meaning that certain flavouring substances have been evaluated by the JECFA only on the basis of these figures," reports the EFSA panel, leading to its demand for more production information from the European flavour industry, "in order to finalise the evaluation." Indeed, data amassed some years ago for the JECFA evaluation (a group of 39 flavouring agents including aliphatic acyclic secondary alcohols and ketones and esters derived from aliphatic secondary alcohols, using the Procedure for the Safety Evaluation of Flavouring Agents) puts the total annual volume of production of the 39 aliphatic secondary alcohols and ketones in this group at approximately 3900 kg in Europe (International Organization of the Flavor Industry, 1995) and 1100 kg in the USA (Lucas et al., 1999). "Approximately 73 per cent and 47 per cent of the total annual production volume in Europe and the USA, respectively, is accounted for by 6-methyl-5-hepten-2-one and 1-octen-3-ol," reported JECFA at the time.
